Protocol Review and Monitoring System Project Summary / Abstract Dana-Farber/Harvard Cancer Center (DF/HCC) has a well-developed system for the review, oversight and support of cancer-relevant protocols, regardless of the source of support, which are developed and conducted at DF/HCC member institutions. The foundations of the centralized infrastructure include: (1) a single Protocol Review and Monitoring System (PRMS); (2) a unified data and safety monitoring process (DSMP); (3) a common institutional review board system (IRB) for review of cancer-relevant research; and (4) shared access to various DF/HCC cores and programs including but not limited to the Biostatistics Core and Early Phase Clinical Research Support (EPCRS). Unified clinical trials informatics for the consortium is managed by Clinical Protocol and Data Management (CPDM). This consolidated data management functions of the office formerly known as the Quality Assurance Office for Clinical Trials with the research informatics function. The Protocol Review and Monitoring System (PRMS) focuses on the scientific merit of protocols, prioritization and feasibility of trial completion. All proposed cancer-relevant research at member institutions must be reviewed and approved by a Scientific Review Committee (SRC) or through expedited administrative scientific review, as permitted by the CCSG for peer-reviewed research, and, on an annual basis, reviewed by the Scientific Progress Review Committee (SPRC). The Office for Human Research Studies (OHRS) manages the operations of the PRMS. Since 2005, the PRMS has been under the direction of Michele Russell-Einhorn, JD, who reports to Drew Memmott, the Associate Director for Administration of DF/HCC. The PRMS received full approval in 2011.